Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Other: Usual Care
Behavioral: automated internet-mediated walking program

Registration Number: NCT01102777

Lead Sponsor: VA Office of Research and Development

Brief Summary: The purpose of this study is to assess the efficacy of an internet-mediated pedometer based intervention that is designed to increase walking and improve function among veterans with chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health-related quality of life at four-months and at one year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the effect of internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization. 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. The long-term objective of this research is to develop, evaluate and disseminate effective, low-cost interventions that improve quality of life for veterans, particularly rural veterans, managing complex chronic conditions.

Detailed Description: Background:

Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Individuals with COPD who undergo a facility-based, exercise-focused pulmonary rehabilitation program experience significant improvements in health related quality of life, dyspnea, and exercise tolerance as well as reduced rates of hospitalization. Unfortunately, only a small percent of individuals with COPD who could benefit from pulmonary rehabilitation have access to and participate in such programs. Moreover, the benefits of short-term pulmonary rehabilitation programs tend to diminish rapidly after the program ends. Rural veterans are less likely to have access to facility-based pulmonary rehabilitation than urban veterans. Health related quality of life in rural veterans with COPD is significantly worse than for veterans with COPD who live in urban areas.

Objectives:

The primary objective of this study was to assess the efficacy of an Internet-mediated, pedometer-based intervention designed to increase walking and health related quality of life for Veterans with COPD. The specific aims of this randomized controlled trial (RCT) with a wait list control were: 1) To test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health related quality of life at four months and at one year; 2) to estimate the effect of the internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization; and 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm.

Methods:

Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving health related quality of life. Eligible and consented patients wore a pedometer to obtain one week of baseline data and then were randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm received iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls were notified that they were enrolled, but that their intervention would start in one year; however, they kept the pedometer and had access to a static webpage. Both groups completed on-line survey assessments at baseline, 4, and 12 months, and were asked to report adverse events on a regular basis. The primary outcome was changes in health related quality of life, as measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific instrument in patients with COPD. Secondary outcomes included days of hospitalization during the one-year intervention period, changes in average daily steps as measured using the study pedometer, self-reported dyspnea, intervention reach, and adverse event rates. The analysis was conducted based \[on the original randomized treatment assignment regardless of participation (an intent-to-treat analysis) and included both a complete case analysis as well as an all case analysis using a linear mixed-effects model. Between-group differences in change scores (4 months or 12 months) were estimated after adjusting for baseline values of the outcome variables.

Status:

This study is completed. Data analysis and manuscript preparation continue.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 307

Inclusion Criteria

Adult >= 40 years old
Diagnosis of COPD, emphysema or chronic bronchitis
Able to walk a minimum of one block
Sedentary, defined by less than 150 minutes of self-reported physical activity per week
Have a doctor or primary care provider in the VA who can provide medical clearance
Competent to give informed consent
Must be a regular email user (check weekly)
Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

Exclusion Criteria

Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Internet-mediated Walking Program	automated internet-mediated walking program	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress

Primary Outcome Measures

Name	Time	Method
Self-Reported Respiratory-Specific Quality of Life	twelve months from randomization	Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

Secondary Outcome Measures

Name	Time	Method
Participant Retention	during study participation, up to twelve months	The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.
Self Reported Dyspnea	twelve months from randomization	Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, "0 - I only get breathless with strenuous exercise." and "4 - I am too breathless to leave the house or I am breathless when dressing.")
Change in Average Daily Step Counts	baseline and final two weeks of the intervention and the two weeks post intervention.	Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.
Study Reach Among Rural Participants	At baseline	Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.
Goal Commitment for Intervention Participants	change from four months and twelve months from enrollment	Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as "Strongly Disagree" and 5 is "Strongly Agree" to the question, "I am strongly committed to pursuing my step count goal." A negative change value indicates lower goal commitment.
Change in Participant Satisfaction	four to twelve months of study participation	Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is "Definitely True" 5 is "Definitely False" to the question, "I would recommend the Taking Healthy Steps walking program to another person with COPD". A negative change value indicates higher satisfaction score.
Days of Hospitalization	during study participation, up to 12 months	Number of days of all-cause hospitalization during study participation.